Topical tacrolimus in atopic dermatitis: Effects of ... - Helda - Helsinki.fi

Methods
Treatment with tacrolimus ointment
In Studies I, II, and V, patients used 0.1% tacrolimus ointment intermittently twice
daily, on all AD affected areas. Patients were instructed to continue applying ointment
for one week after cessation of itch and clearing of the AD lesions and to start the
treatment similarly on areas where AD symptoms reappeared. In Study IV, tacrolimus
0.03% ointment was used on the affected eyelids once daily for the first 4 weeks and
later intermittently depending on the individual response.
Assessment of atopic dermatitis
In Study I, the eczema score, erythema, induration, excoriation, lichenification, and
scaling of the worst AD lesion were each graded on a scale of 0 to 3 and summed
(maximum 15). Changes in eczema score were calculated from baseline to week one,
month 6, and month 12 for each patient. In Studies II and V, both the efficacy and
safety of treatment with tacrolimus were monitored, with patient visits at baseline (day
one); weeks one and 4; and months 3, 6, 9, and 12. BSA was evaluated at baseline and
at weeks one and 4 and months 3, 6, 9, 12, and in Study V every six months thereafter
until month 48. The treatment response for AD was evaluated also by physician’s and
patient’s global assessment (PGA), as in case report forms of the study, on how
satisfactory the treatment had been for the patient’s condition (excellent, very good,
good, fair, or poor). In Study V, patients who sustained an excellent or very good PGA
after month 3 were analyzed as a separate group of patients with the best treatment
response. Adverse events and concomitant medications were followed. Laboratory
assessments (hematology and clinical chemistry including assessments of renal and
hepatic function) were performed on day one, at week one and months 6 and 12. In the
conventional therapy group of Study II, the affected BSA was assessed at baseline and
month 12. No laboratory tests were scheduled.
BSA was evaluated for all subjects once in Study III. In Study IV, a simple scale
was created to measure the symptoms. The severity of blepharitis (scaling,
lichenification, and excoriations of the eyelid skin, thickening of the lid margin,
thinning of lashes) and conjunctivitis (hyperemia, swelling, upper tarsal follicles, and
macropapills) were both assessed on a scale from 0 to 3 (no symptoms, mild, moderate,
or severe). No keratitis score was included, as only three patients showed signs of mild
epithelial punctate keratitis in the first assessment.
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